NCT01801150

Brief Summary

Aim: To assess if six months of treatment with CPAP associated with conventional drug therapy, contribute to improved glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome SAHS)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for phase_4 diabetes

Timeline
Completed

Started Oct 2011

Longer than P75 for phase_4 diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 24, 2015

Status Verified

March 1, 2015

Enrollment Period

3.2 years

First QC Date

November 16, 2012

Last Update Submit

March 19, 2015

Conditions

DiabetesSleep Apnea

Keywords

DiabetesApnea- hypopnea SyndromeGlycemic controlPrevalenceSAHSlife quality

Outcome Measures

Primary Outcomes (1)

  • Glycemic control

    To assess the effect of 6 months of CPAP therapy and conventional treatment on glycemic control in patients with type 2 diabetes and sleep apnea-hypopnea syndrome (SAHS)

    Six months

Secondary Outcomes (1)

  • To determine additional effects of CPAP on insulin resistance in patients with type 2 diabetes and SAHS.

    6 months

Other Outcomes (5)

  • Impact of CPAP on glycemic control

    6 months

  • Quality of life after CPAP

    6 months

  • Inflammatory markers after CPAP

    6 months

  • +2 more other outcomes

Study Arms (2)

lifestyle and diabetes treatment

NO INTERVENTION

Counseil about lifestyle and current diabetes treatment

CPAP nasal treatment

EXPERIMENTAL

Continuous positive airway pressure (CPAP) nasal during the night and current diabetes treatment. Device

Device: CPAP nasal treatment

Interventions

CPAP nasal treatmentDEVICE

Treatment with titred CPAP nasal during the nighttime

CPAP nasal treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects 18 to 75 years old; diagnosis of type 2 diabetes mellitus; treatment with diet; oral antidiabetics or insulin stable in the last month; levels of HbA1c\> 7.5% (if not supported clinic two controls to confirm with a difference not exceeding 0.5%); overweight or obese (BMI ≥ 25 kg/m2)

You may not qualify if:

  • professional drivers, risk profession or respiratory failure; excessive daytime sleepiness is very high (Epworth scale\> 18); morbid obesity (BMI\> 40 kg/m2); CPAP treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario La Paz- IdiPaz

Madrid, Madrid, 28046, Spain

Location

Related Publications (1)

  • Martinez-Ceron E, Barquiel B, Bezos AM, Casitas R, Galera R, Garcia-Benito C, Hernanz A, Alonso-Fernandez A, Garcia-Rio F. Effect of Continuous Positive Airway Pressure on Glycemic Control in Patients with Obstructive Sleep Apnea and Type 2 Diabetes. A Randomized Clinical Trial. Am J Respir Crit Care Med. 2016 Aug 15;194(4):476-85. doi: 10.1164/rccm.201510-1942OC.

    PMID: 26910598DERIVED

MeSH Terms

Conditions

Diabetes MellitusSleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Francisco Garcia-Rio, MD

    Hospital Universitario La Paz, IdiPAZ

    STUDY CHAIR

  • Elizabet Martínez-Cerón, MD

    Hospital Universitario La Paz, IdiPAZ

    PRINCIPAL INVESTIGATOR

  • Alberto Alonso-Fernández, MD

    Hospital Son Espasses

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 16, 2012

First Posted

February 28, 2013

Study Start

October 1, 2011

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

March 24, 2015

Record last verified: 2015-03

Locations

ES(1)